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FDA 510(k) Application Details - K003577
Device Classification Name
Light, Surgical, Fiberoptic
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510(K) Number
K003577
Device Name
Light, Surgical, Fiberoptic
Applicant
STERIS Corporation
2720 GUNTER PARK EAST
MONTGOMERY, AL 36109 US
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RAYMOND URSICK
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Regulation Number
878.4580
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Classification Product Code
FST
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More FDA Info for this Product Code
Date Received
11/20/2000
Decision Date
01/29/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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